Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-03 @ 9:28 PM
Study NCT ID:
NCT04618250
Status:
COMPLETED
Last Update Posted:
2022-05-02
First Post:
2020-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Physical Health in Patients With Psychiatric Disorders in General Practice (SOFIA)
Sponsor:
University of Copenhagen
Organization:
Study Overview
Official Title:
A Cluster Randomized, Pilot Trial of Coordinated, Co-produced Care to Reduce Excess Mortality and Improve Quality of Life in Patients With Severe Mental Illness in General Practice Setting
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOFIA
Brief Summary:
People with a severe mental illness (SMI) have an increased risk for premature mortality, predominantly due somatic health conditions. Evidence indicates that prevention and improved treatment of somatic conditions in patients with SMI could reduce this excess mortality. This paper reports a protocol designed to evaluate the feasibility and acceptability of a coordinated co-produced care programme (SOFIA model) in the general practice setting to reduce mortality and improve quality of life in patients with severe mental illness. The primary outcomes are description of study feasibility (recruitment and retention) and acceptability.
The SOFIA trial is designed as cluster randomized controlled trial targeting general practices in two regions in Denmark. 12 practices will each recruit 15 community-dwelling patients aged 18 and older with severe mental illness (SMI). Practices will be randomized in a ratio 2:1 to deliver a coordinated care program or care-as-usual during a 6 month period. An online randomized algorithm is used to perform randomization. The coordinated care program comprises enhanced educational training of general practitioners and their clinical staff, and prolonged consultations focusing on individual needs and preferences of the patient with SMI. Assessments are administered at baseline, and at end of study period.
If delivery of the intervention in the general practice setting proves feasible, a future definitive trial to determine the effectiveness of the intervention in reducing mortality and improving quality of life in patients with SMI can take place.
The SOFIA trial is designed as cluster randomized controlled trial targeting general practices in two regions in Denmark. 12 practices will each recruit 15 community-dwelling patients aged 18 and older with severe mental illness (SMI). Practices will be randomized in a ratio 2:1 to deliver a coordinated care program or care-as-usual during a 6 month period. An online randomized algorithm is used to perform randomization. The coordinated care program comprises enhanced educational training of general practitioners and their clinical staff, and prolonged consultations focusing on individual needs and preferences of the patient with SMI. Assessments are administered at baseline, and at end of study period.
If delivery of the intervention in the general practice setting proves feasible, a future definitive trial to determine the effectiveness of the intervention in reducing mortality and improving quality of life in patients with SMI can take place.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: